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Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines (Pharmacycare)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pharmacist counselling session with a motivational interview
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Heart Disease focused on measuring pharmacy care, adherence, coronary heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18-yr-old.
  • Both Male/female.
  • Acute coronary syndromes; angina, NSTEMI (non-ST-segment elevation myocardial infarction) /unstable angina, STEMI (ST segment elevation myocardial infarction).
  • Patients included are from high risk group (hypertension , diabetes, hyperlipidemia), as well as patient from low risk group (developed MI with an unknown risk factor).
  • Patients medically treated for secondary prevention of coronary artery disease (dual antiplatelet therapy aspirin plus either clopidogrel, ticagrelor or prasugrel. Beta-blockers, or calcium channel blockers, ACE-inhibitors or ARBs (angiotensin II receptor blocker), and statins).
  • Patients living in the area around East London and who regularly refill prescriptions in the pharmacies involved in the study.

Exclusion Criteria:

  • Congenital heart disease.
  • Complications of myocardial infarction: Arrhythmias, Congestive Heart Failure, Tamponade / Thromboembolic disorder, Rupture (Ventricle, septum, papillary muscle), Aneurysm (Ventricle), Pericarditis, Infection.
  • Patients who do not live in the area around East London and do not regularly refill prescriptions in the pharmacies involved in the study.
  • Patients who do not live independently (living or nursing home residence).
  • Patients with less than one year survival rate.
  • Patients unable to understand oral and written English.

Sites / Locations

  • The London Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pharmacy care group

Controlgroup

Arm Description

patients in this group will receive two counseling sessions with a motivational interview.

patients in this group will receive usual care by pharmacists

Outcomes

Primary Outcome Measures

Change in adherence to cardiovascular medication

Secondary Outcome Measures

Change in blood pressure and LDL-C.
Cost of the intervention.
Cost of the intervention: This will include training of the community pharmacists on motivational interviews. Cost of the community pharmacist intervention in terms of time and material spent on counselling patients and establish if this can be accommodated into a daily schedule of a community pharmacy and how many sessions can one pharmacy manage per day.

Full Information

First Posted
August 5, 2013
Last Updated
April 30, 2015
Sponsor
University College, London
Collaborators
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01920009
Brief Title
Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines
Acronym
Pharmacycare
Official Title
Feasibility and Potential Impact of Community Pharmacy Care Including Motivational Interviews on Adherence to Secondary Prevention Medication in Patients With Coronary Heart Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: In the United Kingdom(UK), about 838,000 men and 394,000 women have had a myocardial infarction (MI) and will need secondary prevention medications. Longterm adherence to secondary prevention therapies remains poor, nonadherence to medication in MI patients ranges from 13-60%(1). Studies show that approximately one fourth of cardiac patients do not refill their cardiac medications (2). Strategies to tackle the burden of non adherence could involve pharmacy care and The New Medicine Service (which is a service provided by community pharmacists to help patients on long term medications for chronic diseases) with a motivational interview incorporated as part of the counselling session of a community pharmacist. Communication of health providers with patients and between health providers could also be an important strategy to improve adherence. Cardiovascular disease is high in all ethnic groups as well as in the general population; however it is the South Asians who have the highest prevalence of coronary heart disease (CHD) (3). In addition, South Asians develop CHD at a younger age, often before the age of 40 years (3). Aim of this study: This study is to investigate the feasibility and potential impact of a pharmacy care intervention involving motivational interviews and referral to the New Medicine Service in coronary heart disease patients on adherence to secondary prevention medication and on outcomes of coronary heart disease. Method: The study is designed as a prospective, controlled feasibility/pilot, intervention study. The study has two phases. In the intervention phase a total of 200 coronary heart disease patients discharged from the London Chest Hospital will be enrolled into the study and followed up for one year. Pharmacies from up to six London Boroughs will be invited to take place in the study. Pharmacies will be randomised using a table of random numbers into intervention site or control site. The pharmacists working in the intervention pharmacies will be invited for training on the delivery of the intervention and on motivational interviewing. The intervention will be performed by community pharmacists. Recruitment of patients will take place in the hospital. In the interview phase 20 patients from South Asian backgrounds will be invited for a telephone interview to study the effect of their beliefs and cultural backgrounds in regards to their adherence to cardiac medication. Outcome measures: The primary outcome measure is self report adherence with coronary artery disease medication employing a standard validated measure. Secondary outcomes are blood pressure and LDL-C (low density lipoprotein cholesterol) in addition to data regarding the feasibility of the intervention. Analysis: Both quantitative and qualitative data analysis will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
pharmacy care, adherence, coronary heart disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacy care group
Arm Type
Active Comparator
Arm Description
patients in this group will receive two counseling sessions with a motivational interview.
Arm Title
Controlgroup
Arm Type
No Intervention
Arm Description
patients in this group will receive usual care by pharmacists
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist counselling session with a motivational interview
Other Intervention Name(s)
Two counseling sessions including a motivational interview, Medication usage review session including a motivational interview, New medicine service session including a motivational interview
Intervention Description
The intervention: The patient will be invited by the community pharmacist for two consultations the first 2 weeks after discharge and the second after 3 months. The intervention group consultation: Community pharmacy consultation around 2 weeks The consultation will take place in the pharmacy a face to face consultation for 20 minutes including; Motivational interview session, the pharmacists will incorporate the key motivational interview skills in their consultation "Express empathy, develop discrepancy, role with resistance, support self efficacy". The sessions will aim to develop a partnership between the pharmacist with the patient and exchange information to facilitate an informed decision. Furthermore both the pharmacist and the patient will negotiate behaviour and reach an agreement. The goal is to access motivation and elicit commitment to change behaviour "in this case would be adherence to life saving medication"
Primary Outcome Measure Information:
Title
Change in adherence to cardiovascular medication
Time Frame
Change in adherence from baseline assessed at 6 months and 12 months.
Secondary Outcome Measure Information:
Title
Change in blood pressure and LDL-C.
Time Frame
Change in blood pressure and LDL-C from baseline assessed at 6 months and 12 months.
Title
Cost of the intervention.
Description
Cost of the intervention: This will include training of the community pharmacists on motivational interviews. Cost of the community pharmacist intervention in terms of time and material spent on counselling patients and establish if this can be accommodated into a daily schedule of a community pharmacy and how many sessions can one pharmacy manage per day.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction/feedback on the pharmacist intervention
Description
This will be assessed by semi-structured telephone interviews conducted by the research pharmacist.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18-yr-old. Both Male/female. Acute coronary syndromes; angina, NSTEMI (non-ST-segment elevation myocardial infarction) /unstable angina, STEMI (ST segment elevation myocardial infarction). Patients included are from high risk group (hypertension , diabetes, hyperlipidemia), as well as patient from low risk group (developed MI with an unknown risk factor). Patients medically treated for secondary prevention of coronary artery disease (dual antiplatelet therapy aspirin plus either clopidogrel, ticagrelor or prasugrel. Beta-blockers, or calcium channel blockers, ACE-inhibitors or ARBs (angiotensin II receptor blocker), and statins). Patients living in the area around East London and who regularly refill prescriptions in the pharmacies involved in the study. Exclusion Criteria: Congenital heart disease. Complications of myocardial infarction: Arrhythmias, Congestive Heart Failure, Tamponade / Thromboembolic disorder, Rupture (Ventricle, septum, papillary muscle), Aneurysm (Ventricle), Pericarditis, Infection. Patients who do not live in the area around East London and do not regularly refill prescriptions in the pharmacies involved in the study. Patients who do not live independently (living or nursing home residence). Patients with less than one year survival rate. Patients unable to understand oral and written English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felicity Smith, Professor
Organizational Affiliation
UCL-School of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Taylor, Professor
Organizational Affiliation
UCL-School of Pharmacy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Consultant Pharmacist Sotiris Antoniou
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The London Chest Hospital
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19707097
Citation
Garavalia L, Garavalia B, Spertus JA, Decker C. Exploring patients' reasons for discontinuance of heart medications. J Cardiovasc Nurs. 2009 Sep-Oct;24(5):371-9. doi: 10.1097/JCN.0b013e3181ae7b2a.
Results Reference
background
PubMed Identifier
18299512
Citation
Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820.
Results Reference
background
PubMed Identifier
16801466
Citation
Gupta M, Singh N, Verma S. South Asians and cardiovascular risk: what clinicians should know. Circulation. 2006 Jun 27;113(25):e924-9. doi: 10.1161/CIRCULATIONAHA.105.583815. No abstract available.
Results Reference
background
PubMed Identifier
31156861
Citation
M A Jalal ZS, Smith F, Taylor D, Finlay K, Patel H, Antoniou S. Impact of pharmacy care upon adherence to cardiovascular medicines: a feasibility pilot controlled trial. Eur J Hosp Pharm. 2016 Sep;23(5):250-256. doi: 10.1136/ejhpharm-2015-000790. Epub 2016 Feb 2.
Results Reference
derived

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Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines

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